Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Canada - Ontario - Mississauga, GSK House, Stevenage, USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia Posted Date: May 26 2022 POTENTIAL REMOTE WORKING OPPORTUNITY The Director, Pharmacovigilance Scientist, SERM provides high level scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the postmarketing setting. The Director ensures that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements. They will identify the need for product labelling updates and drive proactive implementation of risk management initiatives. The Director will lead safety evaluation and risk management activities throughout the product's entire life cycle and shows confidence, credibility and influence at all levels of the organisation and, possibly, externally to GSK. They will be responsible for presenting on the disease area or product area safety strategy at key internal GSK meetings, and fully represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. The Director may deputise for the SERM Head. They will participate in, or lead, cross-GSK activities such as safety advisory panels, interfaces with high levels of GSK outside Pharma Safety on a regular basis and may be recognized as a key player in external international pharmacovigilance activities. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Safety Governance and Risk Management Activities Leads thinking in Pharma Safety around risk management plans and their implementation. For designated products, drives Pharmacovigilance and Risk Management Planning in the clinical matrix and leads production of Global Benefit-Risk Management Plans Leads safety input into regulatory benefit risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities Delivers the clinical safety input into clinical development planning activities Reviews and provides technical approval for Investigator brochures, protocols, informed consents, final study reports and external data monitoring committee charters. May lead or participate in discussion at Global Safety Board for safety related findings in clinical development. Presents safety information at clinical investigator and commercial meetings. Ensures prompt notification to SERM Head of reviewed protocols that are identified as potential PASS Pharma Safety representative on cross functional clinical matrix teams and/or project teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues Establishes Safety Review Teams (SRTs) or co-ordinates leadership of multiple SRTs for projects in development and provides expert review of data and management of safety issues. Escalates safety issues identified through the Safety Review Process to Global Safety Board if necessary, via the SERM Head. Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate Signal Detection, Evaluation and Labelling May be responsible for the signal detection and evaluation process of certain products within the SERM team, as delegated by the SERM Head. Drives signal detection for assigned products using available methodologies.. Makes recommendations to SERM Head for the assessment and prioritisation of safety signals within therapeutic area Proactively leads the assessment of safety data and discusses the results with the SERM Head. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations Leads presentations on labelling recommendations at Global Labelling Committeeand Global Safety Board. Produces regulatory supporting documentation for labelling updates Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests for local label deviations from the company core data sheet Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints In consultation with the product physician and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion Regulatory Reports and Submissions Drives production of periodic regulatory documents (PBRERs, DSURs) according to the agreed process and timelines. Acts as technical consultant on PBRERs for key assets, overseeing strategy. May review PBREs, as delegated by SERM Head Supports the Local Operating Companies by preparing license renewal documentation (e.g. addenda line listings, clinical overviews, summary bridging reports) as required for each market Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts Other SERM Activities Drives the review or production of the SERM component of Safety Data Exchange Agreements and escalates any deficiencies to the SERM Head to ensure quality and integrity of agreement. Advises on the preparation of licensing agreements in therapeutic area of responsibility Participates in due diligence activities by providing expert safety assessments and recommendations Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities Provides support to GSK Legal for product liability litigation, as appropriate Accountable for maintaining personal readiness in response to internal audit or regulatory inspection Leads a complex process improvement initiative within Pharma Safety. Participates in a broader, cross-functional process team within GSK May participate in, or leads, cross-GSK activities such as safety advisory panels, task forces or scientific forums Raises concerns/ issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated Trains, coaches and mentors scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents May deputise for the SERM Head Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Health Care related specialty with 15 plus years of experience in safety and pharmacovigilance OR Doctoral/Master's Degree with 10 plus years of experience Leadership experience in matrix team setting including training, coaching and mentoring employees Experience in medical writing Knowledge of pharmacovigilance regulations and methodologies applicable to SERM activities Experience in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education Knowledge of statistics, and epidemiology relevant to assessing drug utilization and safety at the population level Knowledge of medical and drug terminology and pharmacology Knowledge of clinical development process with drug approval process globally Project Management, Negotiation, & Presentation experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Pharm D or PhD, in Biomedical or Health Care discipline Prior experience contributing to NDAs, BLAs, sNDA, and/or MAAs Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context. Ability to manage and co-ordinate tasks, projects and processes across organisation in complex and critical situations Highly effective communication skills; able to present complex data to groups at all levels of the organisation and externally to GSK Highly developed negotiating and influencing skills, demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality Contributes innovative ideas to address new issues or improve approaches to existing operations with demonstrated ability to take a lead in driving needed change Ability to adjust behaviours and priorities based on changing environment Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes Ability to engage in, and contribute to, broad GSK environment and pharmacovigilance environment outside GSK with confidence, impact, integrity and professionalism Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK *This is a job description to aide in the job posting, but does not include all job evaluation details. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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